OMNIS HEALTH, LLC

Address:1736 River Hills Drive Suite 6,Nashville,TN,37210,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Glucose Dehydrogenase, Glucose (LFR) (5) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2) System, Test, Blood Glucose, Over The Counter (NBW) (2)

Premarket Exempt

No Yes

Clear

HealthWise Embrace TALK Blood Glucose Test Strips (50 ct.) - 00894030002833 Catalog Number :

Device Class : 2

Duns Number: 824763358

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

Embrace TALK control solution HI - 00894030002864 Catalog Number :

Device Description : Embrace TALK control solution L2

Device Class : 1

Duns Number: 824763358

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Embrace TALK Control Solution L1 (LO) - 00894030002871 Catalog Number :

Device Class : 1

Duns Number: 824763358

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Embrace TALK 25 ct. test strip - 00894030002918 Catalog Number :

Device Class : 2

Duns Number: 824763358

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

Embrace TALK 50 ct. test strip (Mail Order) - 00894030002949 Catalog Number :

Device Class : 2

Duns Number: 824763358

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

HealthWise Embrace TALK Pre-Pack (3x12) - 00894030002963 Catalog Number :

Device Description : 3 x Embrace TALK Monitor12 x Embrace TALK Test Strip 50ct.

Device Class : 2

Duns Number: 824763358

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 1

Embrace TALK Blood Glucose Monitor (Pre-Pack) - 00894030002970 Catalog Number :

Device Class : 2

Duns Number: 824763358

Premarket Exempt : No

Product Code : LFR, NBW

Prescription Use : No

Device Count : 1

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